Events

Recall of NEPTUNE 2 WASTE MANAGEMENT SYSTEM - ROVER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRYKER CANADA LP.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52127
  • Event Risk Class
    II
  • Event Initiated Date
    2009-10-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The company has become aware that there is the potential that over time a buildup of surgical waste on the receptacle bearing surfaces may increase the force required to rotate the suction manifold. if the force becomes too high the manifold cannot be rotated - therefore it cannot be inserted or removed. once this occurs there will be no vacuum applied to the suction manifold so the primary function of the affected rover canister is lost.

Device

NEPTUNE 2 WASTE MANAGEMENT SYSTEM - ROVER
  • Model / Serial
    Model Catalog: 0702-001-000 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    Neptune 2 Ultra Rover
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC